Aseptic Processing Technician (2nd Shift)

0-2 years

Not Disclosed

Philadelphia

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: AS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Aseptic Processing Technician (2nd Shift)
Location: Philadelphia, PA 19123
Employment Type: Contract To Hire
Job Category: Scientific
Job Number: 616240
Is Job Remote?: No
Country: United States

Job Overview

Planet Pharma is seeking an Aseptic Processing Technician for a contract-to-hire position. The role focuses on maintaining documentation for processes related to cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations. The position works across various shifts, including evenings, weekends, and holidays, as needed to ensure the manufacturing process is completed.

This position starts on the day shift but will transition to 2nd shift (Tuesday-Friday, 5pm-3am) after training.

Key Responsibilities

Complete training sessions and maintain training documentation.
Execute procedures to ensure consistent, error-free completion of daily job assignments.
Work as part of a team to produce each lot, completing batch records, forms, and documentation.
Comply with quality standards, safety guidelines, and Good Manufacturing Practices (GMP).
Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
Identify errors, report them promptly to management, and participate in root cause analysis and corrective actions.
Adhere to Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP).
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.

Travel

Up to 5% travel may be required.

Required Education, Skills, and Knowledge

Minimum AS degree in biology, biochemistry, bioengineering, or a related field, or equivalent industry experience.
0-2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and downstream processing.
Proficient in Microsoft Office (Excel, Word, Outlook).
Ability to accurately perform basic math (fractions, decimals, percentages).
Ability to work effectively in a fast-paced, team-oriented environment with initiative.
Familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.

Preferred Qualifications

Demonstrated technical knowledge of aseptic processing in cleanroom environments.

Additional Information

Planet Pharma is an equal opportunity employer, celebrating diversity and providing an inclusive environment. Candidates from all backgrounds are encouraged to apply.

Slug: aseptic-processing-technician-philadelphia-pa

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Aseptic Processing Technician (2nd Shift)

Job Description

Job Overview

Key Responsibilities

Travel

Required Education, Skills, and Knowledge

Preferred Qualifications

Additional Information

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